NCT07055399RecruitingPhase 2
Neoadjuvant Iparomlimab and Tuvonralimab Plus Chemotherapy-eclipse for Locally Advanced Cervical Cancer (NICE-CC)
Neoadjuvant Therapy of Iparomlimab and Tuvonralimab Combined With Chemotherapy-eclipse for Locally Advanced Cervical Cancer：A Single-arm, Open-label, Phase II Trial
Source: ClinicalTrials.gov · Last updated 11 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Locally advanced cervical cancer (LACC) remains a significant global health concern with limited treatment options. Recent advancements suggest that using neoadjuvant anti-PD-1 inhibitors in combination with chemotherapy, followed by radical surgery, may be an effective treatment strategy for patients with PD-L1-positive LACC. This study aims to evaluate the efficacy and safety of preoperative treatment with iparomlimab and tuvonralimab-a bifunctional PD-1/CTLA-4 dual blocker-combined with chemotherapy for LACC.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- First submitted
- 17 Apr 2025
- Start date
- 21 Aug 2025
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Fujian Cancer Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT07055399
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 43
- From 21 Aug 2025 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 9、Drug or alcohol abuse
Other illness
- 1、History of other malignancies within 3 years
- 3、Active autoimmune disease, which needs systemic therapy
- 4、Uncontrolled infection, which needs systemic therapy
- 5、History of allogeneic tissue/solid organ transplant
- 6、Serious illness, such as severe mental disorders, cardiac disease, coagulation disorders, digestive system disease, etc
- 7、Active HBV, HCV, or HIV infection
Other
- 2、Participate in other clinical trials at the same time
- 8、Pregnant or lactating female patients
- 10、 Unable or unwilling to sign the informed consent
Who the study is looking for
- 1、Written informed consent
- 2、18-70 years old
- 3、Adequate organ function and ECOG of 0 \~1
- 4、Without systemic therapy at the time of enrollment
- 5、FIGO 2018 stage IB3, IIA2, or IIIC1r
- 6、Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- 7、Measurable lesions could be defined by RECIST v1.1
- 8、Willing to get blood/ tumor tissue tested
- 9、Patients who observed the rules about the scheduled visit, study schedule, and medical examination
- 10、The function of major organs is normal, and the following criteria are met:
- 10.1 Blood routine examination must meet: (no blood transfusion within 14 days)
- Hb≥90g/L:
- ANC≥1.5x10\^9/L; PLT≥100x10\^9/L;
- 10.2 The biochemical examination must meet the following standards BIL \< 1.5 × ULN; ALT and AST \< 2.5xULN; ALB≥ 28 g/L
- 11、Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests, and other research procedures.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.